Hydromorphone is administered to patients to reduce pain. Successful pain management in many of these patients requires maintenance of certain blood levels of hydromorphone throughout the day. One way of obtaining acceptable blood levels, used commonly in the pharmaceutical industry, is providing a dose which contains far more drug than is necessary to obtain the desired blood level. Blood levels shortly after the tablet is ingested reach a maximum or Cmax in a relatively short time, often within hours of ingestion (Tmax) and thereafter, as the body uses, processes and excretes drug from the blood system, the blood level drops. If the Cmax attained is sufficiently high, and the body's clearance of the drug is sufficiently slow, the blood levels may not fall to sub-therapeutic levels for 4-12 hours or even longer. With drugs like hydromorphone, however, this is an impractical and inefficient dosing system. In addition, there is a risk to the patient in that such high initial API levels can cause significant side effects.
Another method of administering hydromorphone involves the use of an extended release mechanism. An extended release can be achieved in many different ways and there are many different release profiles that can be attained. Not only could this strategy reduce the number of doses that need to be taken in a day, it also may prevent one from being exposed to the side effects which can come from unnecessarily high initial blood levels.
Those who seek to abuse hydromorphone to “get high” can be frustrated by such extended and indeed other controlled release strategies. These strategies actively prevent one from obtaining high blood levels of the drug which can cause the euphoria or other physiologic effects which they are actually seeking, but which normal patients would consider an undesirable or even dangerous side effect. Such prescription drug abusers have learned to circumvent controlled release mechanisms by various administrative abuse means including simply chewing extended release tablets or crushing them using a mortar and a pestle for injection or the like. Another way to circumvent controlled release coatings is to attempt to dissolve the dosage form in a solvent such as water or ethanol. The latter can be particularly dangerous as hydromorphone should not be taken with alcohol. Depending upon the extended release formulation, the ethanol or water may act as a solvent, dissolving or eroding the dosage form and circumventing the intended controlled release. The resulting material can then be administered generally, orally, or in a syringe by a drug abuser.
Such abuse can have rather far ranging consequences. For example, cancer patients, patients with post-operative or pre-operative pain, and patients with chronic pains from arthritis or back injuries need to have useful drugs (e.g., hydromorphone) available to them. The potential for abuse, however, is a constant concern to regulators and law enforcement as these prescription drugs may be more freely obtainable than truly illegal illicit substances. There are also the societal problems relating to drug use, which includes the cost of their health care, the cost of their rehabilitation, the increase in crime which may come from supporting their drug habit, and the like.